跳至主要内容
临床试验/NCT04248920
NCT04248920已完成不适用

Clinic to Community© Program for Adults With Epilepsy Admitted to Emergency Departments: A Randomized Controlled Trial

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2022年9月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
Rate of engagement with the Clinic To Community© (C2C) program

研究概览

简要总结

Analysis of emergency department (ED) visits with a billing code for 'epilepsy' or 'seizure' found up to 37% are eligible for deferral. This study is a randomized controlled trial (RCT) of the Clinic To Community© program (C2C) as an intervention for adults with epilepsy visiting emergency departments at a mid size hospital in Ontario, Canada. Participants in the intervention arm receive patient education to improve knowledge of epilepsy and access to community-based services. Participants in the control group are wait-listed and receive patient education 12 months later. The study objective is to successfully implement, recruit and retain participants for this intervention and evaluate whether C2C will reduce the frequency of ED visits, reduce felt stigma and improve quality of life, epilepsy knowledge, and self-management skills.

详细描述

Emergency care for epilepsy can be appropriate and even life-saving, but up to 37% of emergency department (ED) visits by persons with epilepsy (PWE) are potentially deferrable, resulting from persons with known epilepsy and uncomplicated seizures. Past studies have shown that low self-management confidence among PWE leads to frequent emergency visits to the hospital. Other factors associated with increased use of EDs are increased seizure frequency, reduced medication, sub-optimal self-management, increased anxiety, increased depression, increased felt-stigma, and lower social and medical epilepsy knowledge.

In one catchment area in Ontario, Canada, the Southwest Local Health Integration Network (LHIN), there are an estimated 7508 prevalent cases of epilepsy associated with the use of approximately $55 million/year of provincial healthcare services. In addition, there are an estimated 433 incident cases costing an additional $4.6 million/year. Hospital care (including ED visits) accounts for 35.5% of the total cost equating to $21 million/year. Eliminating the 37% of deferrable ED visits equates to saving almost $8 million/year.

The Clinic to Community© (C2C) epilepsy education program has been developed using best practices for patient education. The content has been divided into an introductory 60 minute face-to-face session supported by strategy sheets that can be accessed online at www.clinictocommunity.ca

The Clinic To Community© program recognizes that epilepsy is unique among chronic conditions in that PWE lose their ability to make choices during a seizure and depend on the decisions of others including family, friends and colleagues to keep them safe. Many patients seek care in the ED to reduce their anxiety and for reassurance and that upon discharge from the ED, the inability to receive a prompt specialist appointment leads to the continued use of ED for these same patients.

This is a parallel, pilot randomized controlled trial (RCT) comparing the Clinic To Community© program plus treatment-as-usual (TAU) with TAU only (i.e. wait-list control). This study will not interfere with patients' clinical care. Eligible patients visiting a participating ED will be given information about the study and if they agree, will be referred. The C2C program will be delivered in-person, one-on-one for 60 minutes by appointment on a rolling basis to minimize wait-times and allow timely access to the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Due to the nature of the intervention, it is not feasible for participants and study personnel to be blinded. However, the letter of information (LOI) indicates that the study aims to evaluate outcomes after an ED visit, and, in addition, evaluate the impact of a community engagement program.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults (aged ≥18 years) visiting a participating ED for a seizure or an epilepsy-related concern.
  • •Adults on anti-seizure medication prior to coming to the ED or prescribed anti-seizure medication at the ED.
  • •Providing informed consent and having sufficient English language skills to complete questionnaires and participate in the intervention.

排除标准

  • •Previous participation in the C2C program.
  • •Known diagnosis of psychogenic non-epileptic seizures (PNES).

研究组 & 干预措施

Intervention Group

Experimental

Intervention Group. Participants randomized to the intervention group will complete the C2C program. They will receive an in-person one-on-one 60-minute education session and will be introduced to, and encouraged to participate in, the programs and support services that are provided by Epilepsy Southwestern Ontario (ESWO). As part of the C2C program, participants will be contacted 6 months later for a supplementary consultation over the telephone and to answer any questions. Epilepsy is unique among chronic, episodic disorders in that PWE lose their ability to make choices during a seizure and depend to a greater degree on the decisions of others including family, friends and colleagues. For this reason, we encourage the PWE to invite their support network to attend the patient education sessions.

干预措施: Clinic to Community Education Program (Behavioral)

Waitlist Control Group

Other

Waitlist Control Group. The control group continues TAU and will be followed up 12 months after randomization. The control group will receive C2C after the 12-month follow-up.

干预措施: Clinic to Community Education Program (Behavioral)

结局指标

主要结局

Rate of engagement with the Clinic To Community© (C2C) program

时间窗: Throughout study completion, approximately 2 years

Evaluated by rate of ED referrals, rate of recruitment, rate of retention, and proportion who receive support education.

次要结局

  • Effect of participation in C2C on quality of life(Baseline (0) and 12 months)
  • Effect of participation in C2C on felt stigma using "Epilepsy Stigma Scale"(Baseline (0) and 12 months)
  • Effect of participation in C2C on felt stigma using "Stigma Scale of Epilepsy"(Baseline (0) and 12 months)
  • Frequency of epilepsy-related emergency department (ED) visits over the next 12 months(Baseline (0), and 12 months)
  • Effect of participation in C2C on self-management skills(Baseline (0) and 12 months)
  • Effect of participation in C2C on epilepsy knowledge(Baseline (0) and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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